Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-ERCP Acute Pancreatitis
• Intervention / Treatment: Drug: Normal Saline 0.9% Infusion Solution Bag; Drug: Lactated Ringer

• Study Type: Interventional
• Enrollment (Anticipated): 242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Primary Investigator; Phone Number: 8139743980; Email: ptaunk@health.usf.edu
• Study Contact Backup: Name: Researcher; Phone Number: 2692676151; Email: rpatel19@health.usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

i. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and/or if patient is to undergo a planned endoscopic intervention deemed at high risk:

1. Suspicion of Oddi dysfunction
2. Personal history of post-ERCP pancreatitis
3. More than 8 cannulation attempts
4. Precut sphincterotomy
5. Endoscopic papillary balloon dilation of an intact sphincter
6. Endoscopic pancreatic duct sphincterotomy
7. Ampullectomy
8. Total bilirubin < 1.0

ii. Or possession of two or more of the following minor criteria:

1. Female sex
2. Age under 50 years
3. Personal history of recurrent acute pancreatitis
4. Pancreatic duct injection leading to "acinarization" or over 3 pancreatic duct injections
5. Pancreatic duct cytology acquisition

Exclusion Criteria:

1. Patients aged less than 18
2. Inability to provide informed consent
3. Pregnancy
4. Active acute pancreatitis
5. Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation < 90% on room air), chronic kidney disease (creatinine clearance < 40 mL/min), systolic congestive heart failure (ejection fraction < 45%), cirrhosis, and severe electrolyte disturbance with sodium <130 mEq/L or >150 mEq/L
6. If patient does not undergo a planned high-risk intervention
7. If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis
8. Patients with cholangitis
9. Patients with chronic and/or active pancreatitis
10. Patients with a true NSAID allergy
11. Patients greater than or equal to 75 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Drug: Lactated Ringer; This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
Active Comparator: Control	Drug: Normal Saline 0.9% Infusion Solution Bag; This is a Normal Saline solution infusion before, during, and after the ERCP procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-ercp pancreatitis	The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.	24 hours

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Pushpak Taunk, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Lactated Ringer's; Post-ERCP Acute Pancreatitis; Normal Saline
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: Pro00029546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No